HomeChinaChangzhou Universal Medical Equipment Co., Ltd.

Changzhou Universal Medical Equipment Co., Ltd.

China · Xinbei District
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
11510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 11 510(k), 0 PMA, 44 excluded
Brazil1 confirmed, 3 excluded
Canada1 confirmed, 2 excluded
Manufacturer names merged into this page: UNIVERSAL MEDICAL INC. · CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD
Same-named companies — This database also contains companies with near-identical names: Nanjing Universal Medical Equipment Co., Ltd., Universal Medical Instrument Corp., Universal Medical Products, Inc., Universal Medical Technologies. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Xinbei District

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

21995
21996
11998
12004
22008
22021
12022

Registration details (sample)

MarketIdentifierNameClass / date
USK213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs2022-03-10
USK211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)2021-09-23
USK210145Nitrile Glove Powder Free Blue2021-04-21
BR80119120004LUVA NITRÍLICA BIODEGRADÁVEL PARA PROCEDIMENTOS NÃO CIRÚRGICOSClass I
CA9235HEARTRAKClass II

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